Are you passionate about quality and continuous improvement? My client is seeking a dynamic Quality Manager to take charge of their ISO 9001:2015 Quality Management System (QMS), and oversee Quality Control and Quality Assurance operations. In this role, you will drive key initiatives, evaluate production capabilities, and ensure compliance with customer and regulatory standards.
Client Details
My client are a highly successful manufacturer, who supply into the medical/pharmaceautical industry.
This is a full-time on-site role, based near Beeston, Nottinghamshire.
Description
- Manage and maintain the organisation's QMS, ensuring it meets customer, internal, and regulatory requirements, including overseeing internal and customer audits.
- Lead the investigation and resolution of customer complaints and quality concerns, providing detailed reports and corrective actions.
- Oversee quality-related issues in manufacturing, determining root causes, corrective actions, and implementing solutions.
- Lead investigations on nonconformances, product incidents, and regulatory requirements, ensuring effective documentation and communication.
- Report regularly to senior management on QMS performance, audits, KPIs, and areas for improvement, while leading quarterly management reviews.
- Manage the Supplier Management program through risk assessments, audits, and compliance with internal standards.
- Develop and maintain Quality Control (QC) processes to ensure effective inspections and compliance.
- Drive continuous improvement initiatives using lean/Six Sigma methodologies, advancing the quality programs to meet global customer needs.
- Build and lead a talented team, focusing on hiring, training, and development to meet department and company goals.
Profile
- Extensive knowledge of ISO, cGMP, and medical or pharmaceutical regulatory requirements.
- Experience in ISO 9001 or 13485 QMS implementation, auditing, risk management, and corrective action.
- Strong background in statistical process improvement, root cause analysis, and supplier/vendor management.
- Excellent communication skills, both verbal and written, with the ability to present to various stakeholders.
- Ability to thrive in a fast-paced environment, juggling multiple priorities effectively.
- Deep understanding of global pharmaceutical and biotech regulations.
- Expertise in Quality Systems like ISO 9001, ISO 13485, 21 CFR Parts 210/211, or Part 820.
- Six Sigma Certification, ASQ Certified Quality Engineer, or equivalent experience.
- Strong leadership and MS Office skills.
- Bachelor's degree in Life Sciences, Business Management, or related field.
- 5+ years of experience in a manufacturing or quality environment, with a solid understanding of QMS standards and regulatory requirements.
- Proven track record in Root Cause analysis, Corrective Action, and Process Improvement.
Job Offer
The successful candidate for this Quality Manager position will be offered up to 55,000 plus package (4% pension contribution, Death in Service x3, 25 days holiday plus BH)